TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).
This recall has been terminated (originally issued December 1, 2011).
- Company
- Radiometer America Inc
- Recall Initiated
- September 27, 2011
- Posted
- December 1, 2011
- Terminated
- February 19, 2012
- Recall Number
- Z-0341-2012
- Quantity
- 4 units were distributed.
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm's TCM series monitors. This causes the monitor to interpret the electrode wrongly, causing it to fail all calibrations and never get ready for use.
Distribution
Worldwide Distribution - USA (nationwide) in the state of San Diego, CA.
Lot / Code Info
Part Number: 945-655, Lot Code: DP-06
Root Cause
Employee error
Action Taken
Radiometer contacted the affected U.S. customer and informed them of the recall via telephone on September 27, 2011. Radiometer requested the return of the affected product received from the firm. For questions call (440) 871-0463.
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